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Advanced Granulation Technology(2)

Source: | Date: 2011-02-22 | Hits:
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Introduction  

Attributes of DPM that may negatively impact media processing operations in biopharmaceutical production facilities are: (a) its dusty nature and potential for cross-contamination and employee exposure; (b) extended mixing times required for complete solubilization; (c) the need for materials segregation and multiple component additions especially in serum-free and protein-free formulations; and (d) concerns regarding homogeneity of trace components. We developed a novel process, Advanced Granulation Technology, to resolve these concerns (1,2). We previously reported pilot-scale manufacture of several complex protein-free and chemically-defined media using this technology (3). To assess scale-up capability of the AGT process, we manufactured CD-CHO (a protein-free, chemically-defined medium for growth and production of CHO cells) at 9kg, 90kg, and 500kg scales. We analyzed physical and biochemical parameters and CHO cell growth and biological productivity from reconstituted media at each manufacturing scale. 

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